The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests

Author:

Mathaes Roman,Mahler Hanns-Christian,Buettiker Jean-Pierre,Roehl Holger,Lam Philippe,Brown Helen,Luemkemann Joerg,Adler Michael,Huwyler Joerg,Streubel Alexander,Mohl Silke

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference44 articles.

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2. Sterile Product Packaging – Integrity Evaluation. The U.S. Pharmacopeia 37 General Chapter 1207.

3. In-use contamination of intravenous infusion fluid;Maki;Appl. Microbiol.,1974

4. FDA Guidance for Industry, Container Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, 2008.

5. Practical fundamentals of glass, rubber, and plastic sterile packaging systems;Sacha;Pharma. Develop. Technol.,2010

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